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COVID-19 testing and reporting behaviours in England across different sociodemographic groups: a population-based study using testing data and data from community prevalence surveillance surveys 英格兰不同社会人口群体的 COVID-19 检测和报告行为:一项利用检测数据和社区流行病监测调查数据进行的人口研究。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-23 DOI: 10.1016/S2589-7500(24)00169-9
Sumali Bajaj SM , Siyu Chen DPhil , Richard Creswell DPhil , Reshania Naidoo MD , Joseph L-H Tsui MSc , Olumide Kolade BSc , George Nicholson DPhil , Brieuc Lehmann PhD , James A Hay PhD , Prof Moritz U G Kraemer DPhil , Ricardo Aguas PhD , Prof Christl A Donnelly ScD , Tom Fowler FFPH , Prof Susan Hopkins FMedSci , Liberty Cantrell MSc , Prabin Dahal DPhil , Prof Lisa J White PhD , Kasia Stepniewska PhD , Merryn Voysey DPhil , Ben Lambert DPhil , Lisa J White
<div><h3>Background</h3><div>Understanding underlying mechanisms of heterogeneity in test-seeking and reporting behaviour during an infectious disease outbreak can help to protect vulnerable populations and guide equity-driven interventions. The COVID-19 pandemic probably exerted different stresses on individuals in different sociodemographic groups and ensuring fair access to and usage of COVID-19 tests was a crucial element of England's testing programme. We aimed to investigate the relationship between sociodemographic factors and COVID-19 testing behaviours in England during the COVID-19 pandemic.</div></div><div><h3>Methods</h3><div>We did a population-based study of COVID-19 testing behaviours with mass COVID-19 testing data for England and data from community prevalence surveillance surveys (REACT-1 and ONS-CIS) from Oct 1, 2020, to March 30, 2022. We used mass testing data for lateral flow device (LFD; data for approximately 290 million tests performed and reported) and PCR (data for approximately 107 million tests performed and returned from the laboratory) tests made available for the general public and provided by date and self-reported age and ethnicity at the lower tier local authority (LTLA) level. We also used publicly available data on mean population size estimates for individual LTLAs, and data on ethnic groups, age groups, and deprivation indices for LTLAs. We did not have access to REACT-1 or ONS-CIS prevalence data disaggregated by sex or gender. Using a mechanistic causal model to debias the PCR testing data, we obtained estimates of weekly SARS-CoV-2 prevalence by both self-reported ethnic groups and age groups for LTLAs in England. This approach to debiasing the PCR (or LFD) testing data also estimated a testing bias parameter defined as the odds of testing in infected versus not infected individuals, which would be close to zero if the likelihood of test seeking (or seeking and reporting) was the same regardless of infection status. With confirmatory PCR data, we estimated false positivity rates, sensitivity, specificity, and the rate of decline in detection probability subsequent to reporting a positive LFD for PCR tests by sociodemographic groups. We also estimated the daily incidence, allowing us to calculate the fraction of cases captured by the testing programme.</div></div><div><h3>Findings</h3><div>From March, 2021 onwards, individuals in the most deprived regions reported approximately half as many LFD tests per capita as individuals in the least deprived areas (median ratio 0·50 [IQR 0·44–0·54]). During the period October, 2020, to June, 2021, PCR testing patterns showed the opposite trend, with individuals in the most deprived areas performing almost double the number of PCR tests per capita than those in the least deprived areas (1·8 [1·7–1·9]). Infection prevalences in Asian or Asian British individuals were considerably higher than those of other ethnic groups during the alpha (B.1.1.7) and omicron (B.1.1.529
背景:了解传染病爆发期间寻求检测和报告行为异质性的内在机制有助于保护易感人群并指导以公平为导向的干预措施。COVID-19 大流行可能对不同社会人口群体的个人造成了不同的压力,而确保公平获得和使用 COVID-19 检测是英格兰检测计划的关键要素。我们旨在调查 COVID-19 大流行期间英格兰社会人口因素与 COVID-19 检测行为之间的关系:我们利用 2020 年 10 月 1 日至 2022 年 3 月 30 日期间英格兰的大规模 COVID-19 检测数据和社区流行率监测调查(REACT-1 和 ONS-CIS)数据,对 COVID-19 检测行为进行了基于人群的研究。我们使用了面向公众的侧流装置(LFD;已进行并报告的约 2.9 亿次检测数据)和 PCR(已进行并从实验室返回的约 1.07 亿次检测数据)检测的大规模检测数据,这些数据按日期和自我报告的年龄和种族在下级地方当局(LTLA)一级提供。我们还使用了可公开获得的单个低级别地方当局的平均人口规模估计数据,以及低级别地方当局的种族群体、年龄组和贫困指数数据。我们无法获得按性别分列的 REACT-1 或 ONS-CIS 患病率数据。我们利用机理因果模型对 PCR 检测数据进行去伪存真,得出了英格兰长期病患按自我报告的种族群体和年龄组别分列的每周 SARS-CoV-2 流行率估计值。这种对 PCR(或 LFD)检测数据去伪存真的方法还估算出了检测偏差参数,该参数被定义为感染者与未感染者的检测几率,如果无论感染状况如何,寻求检测(或寻求检测并报告)的几率相同,则该参数接近零。通过 PCR 确证数据,我们估算了假阳性率、灵敏度、特异性,以及按社会人口组别分列的 PCR 检测报告 LFD 阳性后的检测概率下降率。我们还估算了每天的发病率,从而计算出检测计划捕获的病例比例:从 2021 年 3 月起,最贫困地区的人均 LFD 检测次数约为最不贫困地区的一半(中位数比率为 0-50 [IQR为 0-44-0-54])。在 2020 年 10 月至 2021 年 6 月期间,PCR 检测模式呈现出相反的趋势,最贫困地区的人均 PCR 检测次数几乎是最不贫困地区的两倍(1-8 [1-7-1-9])。在阿尔法(B.1.1.7)和奥米克隆(B.1.1.529)BA.1 波中,亚裔或亚裔英国人的感染率大大高于其他种族群体。我们的估计结果表明,在研究期间,英格兰第二支柱部门 COVID-19 检测项目发现了 26-40% 的病例(包括无症状病例),不同贫困水平或种族群体之间没有一致的差异。PCR 的检测偏倚通常高于 LFD,这与无症状和无症状使用这些检测方法的总体政策一致。贫困程度和年龄与平均检测偏差有关;不过,不同贫困程度的不确定区间有所重叠,但特定年龄的模式更为明显。我们还发现,在疫情的大部分时间里,少数民族和老年人不太可能使用 PCR 确证检测,而在自称为 "黑人、非洲人、英国黑人或加勒比海人 "的人群中,报告 LFD 检测阳性的延迟时间可能更长:不同社会人口群体在检测行为上的差异可能反映了弱势人群自我隔离的成本较高、检测可及性的差异、数字扫盲的差异以及对检测效用和感染风险的不同认识。这项研究展示了如何将大规模检测数据与监测调查结合起来使用,以确定公共卫生干预措施在细微层面和不同社会人口群体中的吸收差距。它为监测地方干预措施提供了一个框架,并为政策制定者提供了宝贵的经验,以确保公平应对未来的流行病:资金来源:英国卫生安全局。
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引用次数: 0
Revealing transparency gaps in publicly available COVID-19 datasets used for medical artificial intelligence development—a systematic review 揭示用于医学人工智能开发的 COVID-19 公开数据集的透明度差距--系统综述。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-23 DOI: 10.1016/S2589-7500(24)00146-8
Joseph E Alderman MB ChB , Maria Charalambides MB ChB , Gagandeep Sachdeva MB ChB , Elinor Laws MB BCh , Joanne Palmer PhD , Elsa Lee MSc , Vaishnavi Menon MB ChB , Qasim Malik MB ChB , Sonam Vadera MB BS , Prof Melanie Calvert PhD , Marzyeh Ghassemi PhD , Melissa D McCradden PhD , Johan Ordish MA , Bilal Mateen MBBS , Prof Charlotte Summers PhD , Jacqui Gath , Rubeta N Matin PhD , Prof Alastair K Denniston PhD , Xiaoxuan Liu PhD
During the COVID-19 pandemic, artificial intelligence (AI) models were created to address health-care resource constraints. Previous research shows that health-care datasets often have limitations, leading to biased AI technologies. This systematic review assessed datasets used for AI development during the pandemic, identifying several deficiencies. Datasets were identified by screening articles from MEDLINE and using Google Dataset Search. 192 datasets were analysed for metadata completeness, composition, data accessibility, and ethical considerations. Findings revealed substantial gaps: only 48% of datasets documented individuals’ country of origin, 43% reported age, and under 25% included sex, gender, race, or ethnicity. Information on data labelling, ethical review, or consent was frequently missing. Many datasets reused data with inadequate traceability. Notably, historical paediatric chest x-rays appeared in some datasets without acknowledgment. These deficiencies highlight the need for better data quality and transparent documentation to lessen the risk that biased AI models are developed in future health emergencies.
在 COVID-19 大流行期间,人们创建了人工智能(AI)模型来解决医疗资源紧张的问题。以往的研究表明,医疗数据集往往存在局限性,从而导致人工智能技术出现偏差。本系统性综述评估了大流行期间用于人工智能开发的数据集,发现了一些不足之处。数据集是通过筛选MEDLINE上的文章和使用谷歌数据集搜索确定的。对 192 个数据集的元数据完整性、组成、数据可访问性和伦理因素进行了分析。研究结果显示存在很大差距:只有 48% 的数据集记录了个人的原籍国,43% 的数据集报告了年龄,不到 25% 的数据集包含性、性别、种族或民族。数据标签、伦理审查或同意书方面的信息经常缺失。许多数据集重复使用了可追溯性不足的数据。值得注意的是,一些数据集中出现了历史性的儿科胸部 X 光片,但并未注明。这些缺陷凸显了提高数据质量和文档透明度的必要性,以降低在未来的突发卫生事件中开发出有偏见的人工智能模型的风险。
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引用次数: 0
Strategies for integrating artificial intelligence into mammography screening programmes: a retrospective simulation analysis 将人工智能融入乳腺 X 射线摄影筛查计划的策略:回顾性模拟分析。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-23 DOI: 10.1016/S2589-7500(24)00173-0
Zacharias V Fisches MSc , Michael Ball ScB , Trasias Mukama PhD , Vilim Štih PhD , Nicholas R Payne PhD , Sarah E Hickman PhD , Prof Fiona J Gilbert PhD , Stefan Bunk MSc , Christian Leibig PhD

Background

Integrating artificial intelligence (AI) into mammography screening can support radiologists and improve programme metrics, yet the potential of different strategies for integrating the technology remains understudied. We compared programme-level performance metrics of seven AI integration strategies.

Methods

We performed a retrospective comparative evaluation of seven strategies for integrating AI into mammography screening using datasets generated from screening programmes in Germany (n=1 657 068), the UK (n=223 603) and Sweden (n=22 779). The commercially available AI model used was Vara version 2.10, trained from scratch on German data. We simulated the performance of each strategy in terms of cancer detection rate (CDR), recall rate, and workload reduction, and compared the metrics with those of the screening programmes. We also assessed the distribution of the stages and grades of the cancers detected by each strategy and the AI model's ability to correctly localise those cancers.

Findings

Compared with the German screening programme (CDR 6·32 per 1000 examinations, recall rate 4·11 per 100 examinations), replacement of both readers (standalone AI strategy) achieved a non-inferior CDR of 6·37 (95% CI 6·10–6·64) at a recall rate of 3·80 (95% CI 3·67–3·93), whereas single reader replacement achieved a CDR of 6·49 (6·31–6·67), a recall rate of 4·01 (3·92–4·10), and a 49% workload reduction. Programme-level decision referral achieved a CDR of 6·85 (6·61–7·11), a recall rate of 3·55 (3·43–3·68), and an 84% workload reduction. Compared with the UK programme CDR of 8·19, the reader-level, programme-level, and deferral to single reader strategies achieved CDRs of 8·24 (7·82–8·71), 8·59 (8·12–9·06), and 8·28 (7·86–8·71), without increasing recall and while reducing workload by 37%, 81%, and 95%, respectively. On the Swedish dataset, programme-level decision referral increased the CDR by 17·7% without increasing recall and while reducing reading workload by 92%.

Interpretation

The decision referral strategies offered the largest improvements in cancer detection rates and reduction in recall rates, and all strategies except normal triaging showed potential to improve screening metrics.

Funding

Vara.
背景:将人工智能(AI)整合到乳腺 X 射线摄影筛查中可以为放射科医生提供支持并改善项目指标,但不同技术整合策略的潜力仍未得到充分研究。我们比较了七种人工智能整合策略的项目级绩效指标:我们使用德国(n=1 657 068)、英国(n=223 603)和瑞典(n=22 779)筛查项目中生成的数据集,对将人工智能整合到乳腺放射摄影筛查中的七种策略进行了回顾性比较评估。使用的商用人工智能模型是 Vara 2.10 版,该模型是在德国数据基础上从头开始训练的。我们模拟了每种策略在癌症检出率 (CDR)、召回率和工作量减少方面的表现,并将这些指标与筛查计划的指标进行了比较。我们还评估了每种策略检测出的癌症的分期和等级分布情况,以及人工智能模型对这些癌症进行正确定位的能力:与德国筛查计划(每 1000 次检查的 CDR 为 6-32,每 100 次检查的召回率为 4-11)相比,更换两名读片员(独立人工智能策略)的 CDR 为 6-37(95% CI 6-10-6-64),召回率为 3-80(95% CI 3-67-3-93);而更换一名读片员的 CDR 为 6-49(6-31-6-67),召回率为 4-01(3-92-4-10),工作量减少了 49%。计划级决策转介的 CDR 为 6-85 (6-61-7-11),召回率为 3-55 (3-43-3-68),工作量减少了 84%。与英国方案 8-19 的 CDR 相比,读者级、方案级和推迟到单个读者策略的 CDR 分别为 8-24 (7-82-8-71)、8-59 (8-12-9-06) 和 8-28 (7-86-8-71),召回率没有增加,工作量分别减少了 37%、81% 和 95%。在瑞典数据集上,程序级决策转介将 CDR 提高了 17-7%,但召回率并未提高,同时阅读工作量减少了 92%:决策转诊策略对癌症检出率和召回率的改善最大,除正常分流外,所有策略都显示出改善筛查指标的潜力:资助:瓦拉
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引用次数: 0
Artificial intelligence-enabled electrocardiogram for mortality and cardiovascular risk estimation: a model development and validation study 人工智能心电图用于死亡率和心血管风险评估:模型开发和验证研究。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-23 DOI: 10.1016/S2589-7500(24)00172-9
Arunashis Sau PhD , Libor Pastika MBBS , Ewa Sieliwonczyk PhD , Konstantinos Patlatzoglou PhD , Antônio H Ribeiro PhD , Kathryn A McGurk PhD , Boroumand Zeidaabadi BSc , Henry Zhang BSc , Krzysztof Macierzanka BSc , Prof Danilo Mandic PhD , Prof Ester Sabino MD , Luana Giatti PhD , Prof Sandhi M Barreto PhD , Lidyane do Valle Camelo PhD , Prof Ioanna Tzoulaki PhD , Prof Declan P O'Regan PhD , Prof Nicholas S Peters MD , Prof James S Ware PhD , Prof Antonio Luiz P Ribeiro PhD , Daniel B Kramer MD , Fu Siong Ng PhD

Background

Artificial intelligence (AI)-enabled electrocardiography (ECG) can be used to predict risk of future disease and mortality but has not yet been adopted into clinical practice. Existing model predictions do not have actionability at an individual patient level, explainability, or biological plausibi. We sought to address these limitations of previous AI-ECG approaches by developing the AI-ECG risk estimator (AIRE) platform.

Methods

The AIRE platform was developed in a secondary care dataset (Beth Israel Deaconess Medical Center [BIDMC]) of 1 163 401 ECGs from 189 539 patients with deep learning and a discrete-time survival model to create a patient-specific survival curve with a single ECG. Therefore, AIRE predicts not only risk of mortality, but also time-to-mortality. AIRE was validated in five diverse, transnational cohorts from the USA, Brazil, and the UK (UK Biobank [UKB]), including volunteers, primary care patients, and secondary care patients.

Findings

AIRE accurately predicts risk of all-cause mortality (BIDMC C-index 0·775, 95% CI 0·773–0·776; C-indices on external validation datasets 0·638–0·773), future ventricular arrhythmia (BIDMC C-index 0·760, 95% CI 0·756–0·763; UKB C-index 0·719, 95% CI 0·635–0·803), future atherosclerotic cardiovascular disease (0·696, 0·694–0·698; 0·643, 0·624–0·662), and future heart failure (0·787, 0·785–0·789; 0·768, 0·733–0·802). Through phenome-wide and genome-wide association studies, we identified candidate biological pathways for the prediction of increased risk, including changes in cardiac structure and function, and genes associated with cardiac structure, biological ageing, and metabolic syndrome.

Interpretation

AIRE is an actionable, explainable, and biologically plausible AI-ECG risk estimation platform that has the potential for use worldwide across a wide range of clinical contexts for short-term and long-term risk estimation.

Funding

British Heart Foundation, National Institute for Health and Care Research, and Medical Research Council.
背景:人工智能(AI)支持的心电图(ECG)可用于预测未来疾病和死亡风险,但尚未被临床实践所采用。现有的模型预测不具备个体患者层面的可操作性、可解释性或生物合理性。我们试图通过开发人工智能心电图风险估算器(AIRE)平台来解决以往人工智能心电图方法的这些局限性:AIRE 平台是在一个二级医疗数据集(贝斯以色列女执事医疗中心 [BIDMC])中开发的,该数据集包含来自 189 539 名患者的 1 163 401 张心电图,利用深度学习和离散时间生存模型,通过单张心电图创建患者特异性生存曲线。因此,AIRE 不仅能预测死亡风险,还能预测死亡时间。AIRE 在来自美国、巴西和英国(UK Biobank [UKB])的五个不同的跨国队列中进行了验证,包括志愿者、初级保健患者和二级保健患者:未来的动脉粥样硬化性心血管疾病(0-696,0-694-0-698;0-643,0-624-0-662)和未来的心力衰竭(0-787,0-785-0-789;0-768,0-733-0-802)。通过全表型和全基因组关联研究,我们确定了预测风险增加的候选生物通路,包括心脏结构和功能的变化,以及与心脏结构、生物老化和代谢综合征相关的基因:AIRE 是一个可操作、可解释、生物学上合理的 AI-ECG 风险评估平台,有望在全球广泛的临床环境中用于短期和长期风险评估:资金来源:英国心脏基金会、国家健康与护理研究所和医学研究委员会。
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引用次数: 0
Fairly evaluating the performance of normative models 公平评估规范模型的性能。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-23 DOI: 10.1016/S2589-7500(24)00200-0
Andre Marquand , Saige Rutherford , Richard Dinga
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引用次数: 0
Fairly evaluating the performance of normative models – Authors' reply 公平评估规范模型的性能 - 作者的答复。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-23 DOI: 10.1016/S2589-7500(24)00199-7
Ruiyang Ge , Yuetong Yu , Denghuang Zhan , Sophia Frangou
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引用次数: 0
Lifting the veil on health datasets 揭开健康数据集的面纱。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-23 DOI: 10.1016/S2589-7500(24)00221-8
The Lancet Digital Health
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引用次数: 0
Unleashing the strengths of unlabelled data in deep learning-assisted pan-cancer abdominal organ quantification: the FLARE22 challenge 在深度学习辅助的泛癌症腹部器官量化中释放无标记数据的优势:FLARE22 挑战赛。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-23 DOI: 10.1016/S2589-7500(24)00154-7
Jun Ma PhD , Yao Zhang PhD , Song Gu MSc , Cheng Ge MSc , Shihao Mae BSc , Adamo Young MSc , Cheng Zhu PhD , Prof Xin Yang PhD , Prof Kangkang Meng PhD , Ziyan Huang BSc , Fan Zhang MSc , Yuanke Pan MSc , Shoujin Huang BSc , Jiacheng Wang PhD , Mingze Sun PhD , Prof Rongguo Zhang PhD , Dengqiang Jia PhD , Jae Won Choi MD , Natália Alves MSc , Bram de Wilde PhD , Prof Bo Wang PhD
Deep learning has shown great potential to automate abdominal organ segmentation and quantification. However, most existing algorithms rely on expert annotations and do not have comprehensive evaluations in real-world multinational settings. To address these limitations, we organised the FLARE 2022 challenge to benchmark fast, low-resource, and accurate abdominal organ segmentation algorithms. We first constructed an intercontinental abdomen CT dataset from more than 50 clinical research groups. We then independently validated that deep learning algorithms achieved a median dice similarity coefficient (DSC) of 90·0% (IQR 87·4–91·3%) by use of 50 labelled images and 2000 unlabelled images, which can substantially reduce manual annotation costs. The best-performing algorithms successfully generalised to holdout external validation sets, achieving a median DSC of 89·4% (85·2–91·3%), 90·0% (84·3–93·0%), and 88·5% (80·9–91·9%) on North American, European, and Asian cohorts, respectively. These algorithms show the potential to use unlabelled data to boost performance and alleviate annotation shortages for modern artificial intelligence models.
深度学习在腹部器官自动分割和量化方面显示出巨大的潜力。然而,大多数现有算法都依赖于专家注释,并没有在真实世界的多国环境中进行全面评估。为了解决这些局限性,我们组织了 FLARE 2022 挑战赛,以对快速、低资源和准确的腹部器官分割算法进行基准测试。我们首先构建了一个来自 50 多个临床研究小组的洲际腹部 CT 数据集。然后,我们独立验证了深度学习算法通过使用 50 张标注图像和 2000 张未标注图像,达到了 90-0%(IQR 87-4-91-3%)的中位数骰子相似系数(DSC),这可以大大降低人工标注成本。表现最好的算法成功地推广到了外部验证集,在北美、欧洲和亚洲队列中的 DSC 中值分别达到了 89-4%(85-2-91-3%)、90-0%(84-3-93-0%)和 88-5%(80-9-91-9%)。这些算法显示了使用无标签数据提高性能和缓解现代人工智能模型注释不足的潜力。
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引用次数: 0
Effect of the i2TransHealth e-health intervention on psychological distress among transgender and gender diverse adults from remote areas in Germany: a randomised controlled trial i2TransHealth 电子健康干预对德国偏远地区变性和性别多元化成年人心理困扰的影响:随机对照试验。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-16 DOI: 10.1016/S2589-7500(24)00192-4
Timo O Nieder PhD , Janis Renner MSc , Susanne Sehner MSc , Amra Pepić PhD , Prof Antonia Zapf PhD , Martin Lambert MD , Prof Peer Briken MD , Arne Dekker PhD
<div><h3>Background</h3><div>Transgender and gender diverse (TGD) people in remote areas face challenges accessing health-care services, including mental health care and gender-affirming medical treatment, which can be associated with psychological distress. In this study, we aimed to evaluate the effectiveness of a 4-month TGD-informed e-health intervention to improve psychological distress among TGD people from remote areas in northern Germany.</div></div><div><h3>Methods</h3><div>In a randomised controlled trial done at a single centre in Germany, adults (aged ≥18 years) who met criteria for gender incongruence or gender dysphoria and who lived at least 50 km outside of Hamburg in one of the northern German federal states were recruited and randomly assigned (1:1) to i<sup>2</sup>TransHealth intervention or a wait list control group. Randomisation was performed with the use of a computer-based code. Due to the nature of the intervention, study participants and clinical staff were aware of treatment allocation, but researchers responsible for data analysis were masked to allocation groups. Study participants in the intervention group (service users) started the i<sup>2</sup>TransHealth intervention immediately after completing the baseline survey after enrolment. Participants assigned to the control group waited 4 months before they were able to access i<sup>2</sup>TransHealth services or regular care. The primary outcome was difference in the Brief Symptom Inventory (BSI)-18 summary score between baseline and 4 months, assessed using a linear model analysis. The primary outcome was assessed in the intention-to-treat (ITT) population, which included all randomly assigned participants. The trial was registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT04290286</span><svg><path></path></svg></span>.</div></div><div><h3>Findings</h3><div>Between May 12, 2020, and May 2, 2022, 177 TGD people were assessed for eligibility, of whom 174 were included in the ITT population (n=90 in the intervention group, n=84 in the control group). Six participants did not provide data for the primary outcome at 4 months, and thus 168 people were included in the analysis population (88 participants in the intervention group and 80 participants in the control group). At 4 months, in the intervention group, the adjusted mean change in BSI-18 from baseline was –0·65 (95% CI –2·25 to 0·96; p=0·43) compared with 2·34 (0·65 to 4·02; p=0·0069) in the control group. Linear model analysis identified a significant difference at 4 months between the groups with regard to change in BSI-18 summary scores from baseline (between-group difference –2·98 [95% CI –5·31 to –0·65]; p=0·012). Adverse events were rare: there were two suicide attempts and one participant was admitted to hospital in the intervention group, and in the control group, there was one case of self-harm and one case of self-harm followed by hospital admission.</div></d
背景:偏远地区的变性者和性别多元化者(TGD)在获得医疗保健服务(包括心理保健和性别确认医疗)方面面临挑战,这可能与心理困扰有关。在这项研究中,我们旨在评估为期 4 个月的以 TGD 为基础的电子健康干预对改善德国北部偏远地区 TGD 患者心理困扰的有效性:在德国的一个单一中心进行的随机对照试验中,我们招募了符合性别不协调或性别焦虑标准的成年人(年龄≥18 岁),他们居住在德国北部联邦州之一、汉堡以外至少 50 公里的地方,并随机分配(1:1)到 i2TransHealth 干预组或候补对照组。随机分配是通过计算机代码进行的。由于干预措施的性质,研究参与者和临床工作人员都知道治疗分配,但负责数据分析的研究人员对分配组别进行了屏蔽。干预组的研究参与者(服务使用者)在完成注册后的基线调查后,立即开始接受 i2TransHealth 干预。被分配到对照组的参与者则要等待 4 个月后才能获得 i2TransHealth 服务或常规护理。主要结果是基线和 4 个月之间简短症状量表 (BSI)-18 总分的差异,采用线性模型分析法进行评估。主要结果在意向治疗(ITT)人群中进行评估,意向治疗人群包括所有随机分配的参与者。该试验已在ClinicalTrials.gov注册,编号为NCT04290286.研究结果:2020年5月12日至2022年5月2日期间,共有177名TGD患者接受了资格评估,其中174人被纳入ITT人群(干预组90人,对照组84人)。有 6 名参与者没有提供 4 个月时的主要结果数据,因此有 168 人被纳入分析人群(干预组 88 人,对照组 80 人)。4个月时,干预组的BSI-18与基线相比的调整后平均变化为-0-65(95% CI -2-25至0-96;p=0-43),而对照组为2-34(0-65至4-02;p=0-0069)。线性模型分析表明,4个月后,两组间的BSI-18总评分与基线相比有显著差异(组间差异为-2-98 [95% CI -5-31至-0-65];P=0-012)。不良事件很少发生:干预组有两例自杀未遂,一例入院治疗;对照组有一例自残,一例自残后入院治疗:干预在避免服务对象心理压力恶化方面具有重要临床意义,其效果优于等待名单对照组。这些研究结果支持电子健康服务在TGD医疗保健中的有效性,特别是对偏远地区人群的有效性:资金来源:联邦联合委员会创新委员会:摘要德文译文见补充材料部分。
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引用次数: 0
Correction to Lancet Digit Health 2024; published online Sept 17. https://doi.org/10.1016/S2589-7500(24)00143-2 https://doi.org/10.1016/S2589-7500(24)00143-2.
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2024-10-09 DOI: 10.1016/S2589-7500(24)00220-6
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引用次数: 0
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Lancet Digital Health
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